Ignite Creation Date:
2024-05-06 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03332888
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2017-11-02
Brief Title:
Safety of HMA-CD20 in Patients With HFrEF
Sponsor:
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Organization:
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Study Overview
Official Title:
Phase II Clinical Trial Testing the Safety of a Humanized Monoclonal Antibody Anti-CD20 in Patients With Heart Failure With Reduced Ejection Fraction
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICFEr-RITU2
Brief Summary:
The study is a phase II single-centered single group prospective clinical trial to evaluate the safety of HMA-CD20 doses among stable patients with class IIIIV according to the NYHA classification with HFrEF receiving standard of care therapy The index qualifying HFrEF must have EF lt 40 based on echocardiographic or cardiac MRI techniques heart failure class IIIIV according to the NYHA classificationaged 40-60 years being diagnosed less than 12 months before enrollment of study following the standard heart failure treatment regimen
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None